|Publication number||US4803996 A|
|Application number||US 07/101,812|
|Publication date||Feb 14, 1989|
|Filing date||Sep 28, 1987|
|Priority date||Sep 28, 1987|
|Publication number||07101812, 101812, US 4803996 A, US 4803996A, US-A-4803996, US4803996 A, US4803996A|
|Inventors||H. Herbert Peel, Merle E. Converse, William H. McGinnis, Donald J. Shirley, John P. Prudhomme|
|Original Assignee||Nippon Colin Co., Ltd.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (18), Referenced by (43), Classifications (12), Legal Events (5)|
|External Links: USPTO, USPTO Assignment, Espacenet|
1. Field of the Invention
The present invention generally relates to devices for monitoring the heart and surrounding blood vessels, and more particularly to such a device which provides improved signal conditioning.
2. Description of the Prior Art
Every year, more than 550,000 people die of heart attacks in the United States alone. In fact, heart disease is the number one killer of persons living in the U.S. Heart attacks are usually brought on by the accumulation of fat and other substances within the coronary arteries, those vessels which supply the heart itself with oxygen and nutrient-rich blood.
Research scientists are getting closer to the secret of preventing heart attacks. The most important aspect of prevention is detecting the presence of arteriosclerosis before it advances to a critical stage. There are many instruments currently in use for invasive and noninvasive measurement of various cardiac parameters. Techniques include ballistocardiography, electrical impedance measurements, ultrasonics, and vibrocardiography. The present invention is more related to traditional cardiac monitoring using electrocardiograms (ECG) and phonocardiograms (PCG).
The ECG signals resulting from the electrical activity of the cardiac muscle are extremely valuable diagnostic indicators when viewed by an experienced cardiologist. Certain abnormalities in these signals can be indicative of different types of heart disorders. Similarly, acoustic patterns taken via PCG may also provide useful information. The difficulty in recording this data, however, lies in the fact that stray electrical potentials can distort the measurements and obscure useful information hidden in the instrumentation output. Signals in analog form are often recorded on magnetic tape, then reproduced at a later time for conversion to digital form for processing. When the connection is made between the recorder output and the processing equipment, powerline noise can be introduced, in addition to circulating electric currents in ground loops.
Another problem arises in placement of the electrodes or transducers on the human body. Any such devices should have a high degree of isolation from the AC powerline and from the powerline ground for safety reasons. Commercially available magnetic tape recorders do not have the required input circuit isolation. Thus, the recorders cannot be connected directly to the electrodes or transducers, creating further potential for signal loss.
Finally, even if the signals could be recorded without distortion, it has been found that certain low-frequency components of the acoustic signal having a relatively large amplitude tend to drown out the higher-frequency components. Much vital diagnostic information is thereby lost.
It would, therefore, be desirable and advantageous to devise a system for monitoring the ECG and PCG of the heart whereby excessive external noise is minimized. The system should allow for connection of the recorder to the electrodes and transducers without introducing ground loop currents, and should also provide a means of preserving high-frequency acoustic signals for later processing.
Accordingly, the primary object of the present invention is to provide a monitoring system which accurately records electrical and acoustical signals from the heart.
Another object of the invention is to provide such a system which has a high degree of isolation between the AC powerline and the electrodes attached to the patient.
Yet another object of the invention is to provide a monitoring system which prevents ground loop currents between recording and processing units.
Still another object of the invention is to provide a cardiovascular monitor capable of supplying electrical and acoustical signals to a recorder in such a fashion that high-frequency components of the acoustical signal are not over-powered by the larger amplitude low-frequency components.
The foregoing objects are achieved in a cardiovascular monitor having a signal conditioner, a conventional recorder, and a recorder/processor interface unit. The signal conditioner isolates the ECG and PCG signals from the recording unit and further modifies the acoustical signal into separate low- and high-frequency channels. Both the signal conditioner and the recorder/processor interface unit employ isolation amplifiers and isolation transformers having extensive shielding and filtering.
The novel features believed characteristic of the invention are set forth in the appended claims. The invention itself, however, as well as a preferred mode of use, further objects and advantages thereof, will best be understood by reference to the following detailed description of illustrative embodiments when read in conjunction with the accompanying drawings, wherein:
FIG. 1 is a block diagram showing the general components of the cardiovascular monitoring system.
FIG. 2 is a schematic of the signal conditioner of the present invention.
FIG. 3 is a schematic of the recorder/processor interface unit of the present invention.
With reference now to the figures, and in particular with reference to FIG. 1, there is depicted a block diagram showing the general arrangement of cardiovascular monitor 10. Cardiovascular monitor 10 is generally comprised of electrocardiogram electrodes 12, phonocardiogram microphone 14, signal conditioner and isolater 16, recorder 18, interface unit 20, and processor 22. ECG electrodes are known in the art. PCG microphones are also known, and generally have piezoelectric crystals which pick up internal acoustical activity. The inventors prefer using a PCG microphone having transducers with a 0.01 microfarad capacitance per element.
ECG electrodes 12 are placed on the body along with PCG microphone 14. An acoustic microphone 15 may optionally be used for filtering out ambient noise occurring during recording. The inventors have used model numbers SMll and SMllCN manufactured by Shure Electronics. The leads from ECG electrodes 12 and PCG microphone 14 are connected to signal conditioner/isolator 16 which prepares the signals for recorder 18. Input protection resistors are usually employed in connecting the leads, having around a 1 watt rating and 100 kilo-ohm resistance. Recorder 18 is a conventional magnetic tape recorder, such as that manufactured by Racal of Irvine, Calif., under the trade name STOREHORSE, and is powered by a standard 120 volt AC powerline. In playback mode, recorder 18 outputs the recorded signal to a recorder/processor interface unit 20 which further conditions the signal for input into the data processor 22. Processor 22 typically converts the analog signal to digital form and performs any one of a number of data analysis functions on the digital data. The present invention does not concern itself with the processing of the extracted information.
The design of signal conditioner 16 is further illustrated in FIG. 2. Cables from ECG electrodes 12 are connected to the input of an ECG amplifier 24. This circuit converts the three-wire raw input signal to a two-wire output signal. ECG amplifiers are known, and a suitable unit may be purchased from the Hewlett Packard Co. ECG amplifier 24 should incorporate low leakage input amplifiers. These wires are then connected to the input of an isolation amplifier 26.
Isolation amplifier 26 provides protection against powerline leakage and converts the raw ECG signal into a single-ended isolated output signal having a common connection to the signal conditioner ground. Isolation amplifiers are familiar to those skilled in the art. They generally provide full isolation between input, output, and power supply ports. Thus, the patient is properly protected from surges or breakdowns in signal conditioner 16 or recorder 18. Isolation amplifier 26 should have a high input impedance (about 100 mega ohms), input voltage ratings of at least 10 volts (differential range), and a rated output of ±10 volts on a 2000 ohm load. A power supply of 15 volts DC is usually required. The inventors have found that the isolation amplifier manufactured by Analog Devices of Norwood, Mass., under model No. AD295, is preferable. The present invention therefore provides a high degree of isolation between the patient and the DC powerline.
The single-ended ECG signal is applied to the control input of a voltage-controlled oscillator or modulator 28 to produce a frequency-modulated (FM) signal. A center frequency of about 7 kHz with a deviation of ±2 kHz has been found satisfactory for this purpose. The modulated ECG signal is then combined with the PCG signal in a resistive summing circuit (described below).
The leads from PCG microphone 14 are connected to the input of another isolation amplifier 30, identical to amplifier 26, which again protects against powerline leakage and converts the raw PCG signal to a single-ended output having a common connection to the signal conditioner ground. The isolated power port of amplifier 30 provides voltage to the transducer (not shown) in microphone 14. The isolated PCG signal is then divided into two circuit paths or limited signals, according to the frequency ranges desired. It has empirically been found that frequencies in the range of 100 to 1000 Hz contain important information on the condition of the coronary arteries; this bandwidth is difficult to analyze if lower-frequency components (i.e., below 100 Hz) are included, as the low-frequency components are relatively large in amplitude. Therefore, the PCG signal is routed to both low-pass filter 32 (PCG1) and bandpass filter 34 (PCG2).
Low-pass filter 32 passes signal frequencies below 1000 Hz, attenuating high frequency noise. Generally, the lowest frequency signal from the PCG microphone is about 20 Hz. The gain of this channel is set low enough to avoid overloading due to the large amplitude low-frequency components. Where noise above 1000 Hz is negligible, low-pass filter 32 is unnecessary. This channel is then coupled with the modulated ECG signal from modulator 28 in summing circuit 36. As one skilled in the art will appreciate, many conventional recorders have only two channels, so recordation of three different signals (ECG, PCG1, and PCG2) requires multiplexing. The inventors prefer to multiplex the signals by frequency division, using modulator 28 and summing circuit 36. The multiplexed signal then passes through isolation transformer 38 to the first channel of recorder 18. Of course, if a 4-channel or 16-channel recorder is used, multiplexing is not necessary.
Isolation transformer 38 is a high-impedance transformer responsive to frequencies between 20 and 1000 Hz. The tranformer must be balanced to insure proper transmission of the multiplexed signal. The inventors prefer to use the transformer made by TRW-UTC Transformers of New York, N.Y., model No. 0-26.
The portion of the PCG signal lying within the range of 100 to 1000 Hz (PCG2) passes through bandpass filter 34, which attenuates signal components at frequencies below 100 Hz. Filter 34 may alternatively be a high-pass filter. The signal then passes through isolation transformer 40 to the second channel of recorder 18. Isolation transformer 40 is identical to transformer 38. The PCG2 channel must be maintained at high quality and high dynamic range as this signal is used in the data processor 22 to correlate the acoustic heart signals with the medical condition of the heart. Isolation transformers 38 and 40 prevent ground loop currents between signal conditioner 16 and recorder 18 which could adulterate the PCG and ECG signals.
After recording the ECG and PCG information, the data may be played back into data processor 22 at a later time. This is accomplished by means of recorder/processor interface unit 20. Recorder/processor interface unit 20 is shown in more detail in FIG. 3. The combined ECG and PCG1 signal from the first channel of recorder 18 is coupled to discriminator 42 by coaxial cable 43 having a common connection to the ground of recorder 18, whereby the FM signal is demodulated to recover the ECG signal. The separated ECG signal is then output to processor 22, via isolation amplifier 44. Processor 22 should have at least three input ports. Isolation amplifier 44 is identical to amplifiers 26 and 30, and prevents powerline noise or ambient currents from flowing on the shields of the input cables. A low impedance output is provided to drive the cables connecting the amplifier output to the data processor unit 22. Although amplifiers 44 and processor 22 are separately connected to the AC powerline, the inventors have found that ground loop currents flowing therebetween are negligible.
Signals from channel 1 of recorder 18 are also applied to the input of another low-pass filter 46. This filter attenuates the frequency components above 1000 Hz, eliminating the ECG FM signal. The PCG1 signal in the frequency range of 20 to 1000 Hz is passed to another isolation amplifier 44 and then to processor 22.
The PCG2 signal is also passed to processor 22 via a third isolation amplifier 44. As with the channel 1 signal, the PCG2 signal travels in a coaxial cable 48 having a common connection to the ground of recorder 18. Finally, a spare channel is provided for other signals, such as the signal from an acoustic microphone which may be used in conjunction with the PCG microphone 14. The acoustic microphone (not shown) could be used to identify ambient noise in the room in which the other measurements are taken.
As an alternative embodiment of the present invention, the signal conditioner 16 and/or recorder/processor interface unit 20 could be manufactured integrally with recorder 18. In this embodiment, isolation amplifiers 26 and 30 would provide output signals having common connections to the recorder ground. Also, isolation transformers 38 and 40 would be unnecessary as there would be no ground loop currents. It should further be understood that interface unit 20 may be used for any recorder/processor system and not just those dealing with cardiovascular monitoring.
Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiment, as well as alternative embodiments of the invention will become apparent to persons skilled in the art upon reference to the description of the invention. It is therefore contemplated that the appended claims will cover such modifications that fall within the true scope of the invention.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US3442264 *||Jun 4, 1964||May 6, 1969||Joseph R Levitt||Data processing method and means|
|US3565058 *||Oct 4, 1967||Feb 23, 1971||Peter B Mansfield||Monitoring apparatus with audio output frequency responsive to ekg signal amplitude|
|US3650264 *||Dec 2, 1969||Mar 21, 1972||Philips Corp||Apparatus for electro-medical investigation|
|US3690313 *||Oct 9, 1970||Sep 12, 1972||Mennen Greatbatch Electronics||Electrically isolated signal path means for a physiological monitor|
|US3732868 *||Mar 3, 1971||May 15, 1973||Philips Corp||Device for the audible reproduction of a cardiogram with speech-like sounds|
|US3760100 *||Jul 30, 1971||Sep 18, 1973||Us Army||Audio electrocardiogram monitor|
|US3830227 *||Sep 15, 1969||Aug 20, 1974||Green H||Hand-held cardiac sound tone diagnostic device and method|
|US3858034 *||Oct 19, 1973||Dec 31, 1974||Del Mar Eng Lab||Electrocardiac computer|
|US3908641 *||Jun 7, 1974||Sep 30, 1975||Birtcher Corp||Electrocardiograph with improved stylus control circuits|
|US4203451 *||Mar 17, 1978||May 20, 1980||Panico Joseph J||Cardiovascular analysis, method and apparatus|
|US4364397 *||Jan 23, 1980||Dec 21, 1982||Medtronic, Inc.||Apparatus for monitoring the rhythm of a patient's heartbeat|
|US4417306 *||Jan 7, 1982||Nov 22, 1983||Medtronic, Inc.||Apparatus for monitoring and storing utilizing a data processor|
|US4425922 *||Apr 7, 1981||Jan 17, 1984||Bioresearch Inc.||Electrical method and apparatus for non-invasively detecting abnormal flow in conduits|
|US4450527 *||Jun 29, 1982||May 22, 1984||Bomed Medical Mfg. Ltd.||Noninvasive continuous cardiac output monitor|
|US4506678 *||Jul 9, 1982||Mar 26, 1985||Healthdyne, Inc.||Patient monitor for providing respiration and electrocardiogram signals|
|US4576178 *||Mar 28, 1983||Mar 18, 1986||David Johnson||Audio signal generator|
|US4630204 *||Feb 21, 1984||Dec 16, 1986||Mortara Instrument Inc.||High resolution ECG waveform processor|
|US4679570 *||Nov 13, 1984||Jul 14, 1987||Phonocardioscope Partners||Phonocardioscope with a liquid crystal display|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US4976681 *||Apr 27, 1988||Dec 11, 1990||Aries Medical, Inc.||Pacer interface device|
|US4993421 *||Jul 20, 1990||Feb 19, 1991||Thornton William E||Cardiac monitoring system|
|US5010889 *||Feb 4, 1988||Apr 30, 1991||Bloodline Technology||Intelligent stethoscope|
|US5036856 *||Jul 19, 1990||Aug 6, 1991||Thornton William E||Cardiovascular monitoring system|
|US5036857 *||Oct 26, 1989||Aug 6, 1991||Rutgers, The State University Of New Jersey||Noninvasive diagnostic system for coronary artery disease|
|US5042499 *||Aug 2, 1990||Aug 27, 1991||Frank Thomas H||Noninvasive electrocardiographic method of real time signal processing for obtaining and displaying instantaneous fetal heart rate and fetal heart rate beat-to-beat variability|
|US5080105 *||Jul 19, 1990||Jan 14, 1992||Thornton William E||Cardiovascular monitoring system|
|US5086776 *||Mar 6, 1990||Feb 11, 1992||Precision Diagnostics, Inc.||Apparatus and method for sensing cardiac performance|
|US5131399 *||Aug 6, 1990||Jul 21, 1992||Sciarra Michael J||Patient monitoring apparatus and method|
|US5159932 *||Feb 7, 1992||Nov 3, 1992||Seismed Instruments, Inc.||Myocardial ischemia detection system|
|US5218969 *||Dec 17, 1990||Jun 15, 1993||Blood Line Technology, Inc.||Intelligent stethoscope|
|US5411534 *||Jul 13, 1994||May 2, 1995||Minnesota Mining And Manufacturing Company||Electrical safety system for electrical device|
|US5418686 *||Jun 17, 1994||May 23, 1995||Minnesota Mining And Manufacturing Company||Electrical safety system for electrical device|
|US5807268 *||Oct 18, 1996||Sep 15, 1998||Medacoustics, Inc.||Disposable sensing device with contaneous conformance|
|US6193668||Nov 9, 1998||Feb 27, 2001||Medacoustics, Inc.||Acoustic sensor array for non-invasive detection of coronary artery disease|
|US6243599||Apr 16, 1999||Jun 5, 2001||Medacoustics, Inc.||Methods, systems and computer program products for photogrammetric sensor position estimation|
|US6261237||Aug 20, 1998||Jul 17, 2001||Medacoustics, Inc.||Thin film piezoelectric polymer sensor|
|US6278890||Nov 9, 1998||Aug 21, 2001||Medacoustics, Inc.||Non-invasive turbulent blood flow imaging system|
|US6478744||Dec 18, 2000||Nov 12, 2002||Sonomedica, Llc||Method of using an acoustic coupling for determining a physiologic signal|
|US6478746||Dec 11, 2000||Nov 12, 2002||Medacoustics, Inc.||Acoustic sensor array for non-invasive detection of coronary artery disease|
|US6574494||Apr 6, 2001||Jun 3, 2003||Medacoustics, Inc.||Methods, systems and computer program products for photogrammetric sensor position estimation|
|US6699201||Nov 29, 2001||Mar 2, 2004||Medacoustics, Inc.||Acoustic window identification|
|US6939308||Nov 8, 2002||Sep 6, 2005||Medacoustics, Inc.||Acoustic sensor array for non-invasive detection of coronary artery disease|
|US7299083||Dec 9, 2004||Nov 20, 2007||Signalife, Inc.||Electrode for, and method of, indicating signal characteristics at particular positions in a patient's body|
|US7395109||Dec 9, 2004||Jul 1, 2008||Signalife, Inc.||System for, and method of, monitoring heartbeats of a patient|
|US7416531||Oct 4, 2002||Aug 26, 2008||Mohler Sailor H||System and method of detecting and processing physiological sounds|
|US8000779||Sep 7, 2007||Aug 16, 2011||Vasamed, Inc.||Impedance cardiography system and method|
|US20030069506 *||Nov 8, 2002||Apr 10, 2003||Chassaing Charles E.||Acoustic sensor array for non-invasive detection of coronary artery disease|
|US20040068195 *||Oct 2, 2002||Apr 8, 2004||Louis Massicotte||Method and apparatus for wearable digital wireless ECG monitoring|
|US20040193028 *||Mar 28, 2003||Sep 30, 2004||Vascular Control Systems, Inc.||Uterine tissue monitoring device and method|
|US20050004482 *||Jul 1, 2003||Jan 6, 2005||Budimir Drakulic||Amplified system for determining parameters of a patient|
|US20050059896 *||Sep 17, 2003||Mar 17, 2005||Budimir Drakulic||Apparatus for, and method of, determining the condition of a patient's heart|
|US20060129052 *||Dec 9, 2004||Jun 15, 2006||Budimir Drakulic||System for, and method of, monitoring heartbeats of a patient|
|US20090143691 *||Jun 30, 2008||Jun 4, 2009||Signalife, Inc.||System for, and method of, monitoring heartbeats of a patient|
|US20090292217 *||Sep 7, 2007||Nov 26, 2009||Daniel Bartnik||Impedance cardiography system and method|
|US20110160601 *||Dec 30, 2009||Jun 30, 2011||Yang Wang||Wire Free Self-Contained Single or Multi-Lead Ambulatory ECG Recording and Analyzing Device, System and Method Thereof|
|EP0467502A2 *||Apr 11, 1991||Jan 22, 1992||William Edgar Thornton||Improved cardiovascular monitoring system|
|EP0467502A3 *||Apr 11, 1991||Mar 18, 1992||William Edgar Thornton||Improved cardiovascular monitoring system|
|EP0468611A2 *||Jan 24, 1991||Jan 29, 1992||William Edgar Thornton||Musculoskeletal activity monitoring system|
|EP0468611A3 *||Jan 24, 1991||Mar 18, 1992||William Edgar Thornton||Musculoskeletal activity monitoring system|
|WO1994008507A1 *||Oct 13, 1993||Apr 28, 1994||Aspect Medical Systems, Inc.||Monitor and method for acquiring and processing electrical signals relating to bodily functions|
|WO2008031030A2 *||Sep 7, 2007||Mar 13, 2008||Optical Sensors Incorporated||Improved impedance cardiography system and method|
|WO2008031030A3 *||Sep 7, 2007||Jul 3, 2008||Optical Sensors Inc||Improved impedance cardiography system and method|
|U.S. Classification||600/523, 600/509, 600/528|
|International Classification||A61B5/0428, A61B7/04, A61B5/0436|
|Cooperative Classification||A61B5/0436, A61B5/04282, A61B7/04|
|European Classification||A61B7/04, A61B5/0428B, A61B5/0436|
|Sep 28, 1987||AS||Assignment|
Owner name: SOUTHWEST RESEARCH INSTITUTE, 6220 CULEBRA ROAD, S
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNORS:PEEL, H. HERBERT;CONVERSE, MERLE E.;MC GINNIS, WILLIAM H.;AND OTHERS;REEL/FRAME:004803/0412
Effective date: 19870922
Owner name: NIPPON COLIN COMPANY, LTD.
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST.;ASSIGNOR:SOUTHWEST RESEARCH INSTITUTE;REEL/FRAME:004809/0866
Effective date: 19870922
Owner name: SOUTHWEST RESEARCH INSTITUTE, 6220 CULEBRA ROAD, S
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PEEL, H. HERBERT;CONVERSE, MERLE E.;MC GINNIS, WILLIAM H.;AND OTHERS;REEL/FRAME:004803/0412
Effective date: 19870922
|May 3, 1991||AS||Assignment|
Owner name: COLIN ELECTRONICS CO., LTD. A COMPANY OF JAPAN
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST EFFECTIVE;ASSIGNOR:NIPPON COLIN CO., LTD., A CORPORATION OF JAPAN;REEL/FRAME:005689/0276
Effective date: 19910201
|Jul 8, 1992||FPAY||Fee payment|
Year of fee payment: 4
|May 8, 1996||FPAY||Fee payment|
Year of fee payment: 8
|Jul 26, 2000||FPAY||Fee payment|
Year of fee payment: 12